Standard Operating Procedure for Equipment Maintenance Log Review in Biosimilar Manufacturing

Department	Biosimilars
SOP No.	SOP/BS/130/2025
Supersedes	SOP/BS/130/2022
Page No.	Page 1 of 11
Issue Date	04/05/2025
Effective Date	06/05/2025
Review Date	04/05/2026

1. Purpose

To define the procedure for periodic review and verification of equipment maintenance logs to ensure compliance with preventive maintenance (PM) schedules, traceability, and GMP readiness in biosimilar manufacturing facilities.

2. Scope

This SOP applies to all production and QC equipment including bioreactors, incubators, autoclaves, centrifuges, chromatography skids, and HVAC systems installed within biosimilar manufacturing units.

3. Responsibilities

• Engineering Department: Maintain equipment logs and perform maintenance activities.
• User Departments (Production/QC): Inform engineering of maintenance needs and verify completion status.
• QA: Periodically review maintenance logs and ensure corrective actions are closed before batch release.

4. Accountability

The Head of Engineering is accountable for implementing the preventive maintenance schedule and ensuring that all equipment maintenance is documented and reviewed according to regulatory requirements.

5. Procedure

5.1 Maintenance Log Format and Structure

1. Each equipment must have a dedicated logbook or system-generated maintenance file.
2. Entries must include:
   • Equipment ID and Location
   • Date of Activity
   • Type of Maintenance (Routine, Breakdown, Calibration)
   • Performed By and Checked By

5.2 Review Frequency

1. QA shall review equipment maintenance logs on a:
   • Monthly Basis – Critical Equipment
   • Quarterly Basis – Supportive Equipment

5.3 Review Parameters

1. QA shall verify:
   • Timely completion of preventive maintenance
   • Adherence to equipment calibration schedule
   • Closure of breakdowns and deviation reports
   • Legibility and completeness of entries
2. Record remarks in Annexure-1: Maintenance Review Checklist.

5.4 Deviation and Delay Handling

1. Any missed maintenance or overdue activity must be recorded in Annexure-2: Maintenance Deviation Log.
2. Engineering shall initiate a Corrective and Preventive Action (CAPA) for repeated delays.

5.5 Archival and Record Retention

1. Completed maintenance logs must be archived in the Engineering document control room for 5 years.
2. Electronic records must be backed up as per SOP/BS/122/2025 on control system backup.

6. Abbreviations

• PM: Preventive Maintenance
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance

7. Documents

1. Maintenance Review Checklist – Annexure-1
2. Maintenance Deviation Log – Annexure-2

8. References

• WHO TRS 986 Annex 2 – GMP for Biologics
• EU GMP Chapter 4 – Documentation
• ISPE Baseline Guide: Commissioning and Qualification

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Maintenance Review Checklist

Equipment ID	Reviewed Date	Reviewed By	Remarks	Status
BR-100L	04/05/2025	Sunita Reddy	PM done on time	Compliant

Annexure-2: Maintenance Deviation Log

Deviation No.	Date	Equipment ID	Description	CAPA Reference
DEV-MNT-006	02/05/2025	CHSKID-02	PM delayed by 5 days	CAPA-0125

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added deviation log and electronic record reference	Compliance alignment